1
414 SPO Abstracts 425 TREATMENT OF PREGNANCY WSS (RPL) DUE TO "LUPUS ANTICOAGULANTS (LAC)" BY LOW-DOSE ASPIRIN (LDA) AND PREDNISONE. I.H. Harger, S.A. Laifer, Dept Ob/Oyn, Univ. of Pittsburgh Sch of Med, Pittsburgh, PA. OBJECTIVE: To ascer14in the complications and the efficacy of LOAiprednisone therapy in women with pregnancy 1088 and LAC. STUDY DESIGN: During 1986-92, 231 RPL patients were te&ted for LAC with an activated partial thromboplastin time (aP'IT) and a tissue thromboplastin index (TIl, normal value < 1.3). The diagnolis of LAC was estshlished if two TIl valu .. were 2: 1.3 or if a prolonged aYIT was measured in patient's plasma but did not correct to normal by I: I mixing with normal plasma. We excluded RPL patients baving only anticardiolipin antibodies. We treated 23 pregnancieo in 18 women with LOAiprednisone for RPL associated with LAC. Therapy with LDAlprcdnilODc was initiated as soon u • viable pregnancy or a LAC w .. diagnosed. Therapy was continued Until delivery in all but 1 case. Prednisone dose was minimized by measuring TIl every 2 weeks and adjusting the dose to maintain a ITI S 1.2 and to correct the aPlT. RESULTS: Of the 23 pregnancies, there were 4 (17%) first-trimester spontanco ... abortion. and 2 (9%) second-trimester fetal denth.. Of 17 surviving neonateo (74%), 6 delivered after 37 weeks and 11 before 37 weeks (mean 36.3 ±2.2 weeks; range 32.6-40.4 weeks). Prcterm premature rupture of membranes occurred in 3 pregnancies, prceclarnplia in 3, and 3 lmall-for- gestational age neonateo were delivered (2 stillborn). Mean birtbweight of 17 surviving neonaleo was 284Sg±6SOg (range 1420-3920g). Mean daily prednisone doac W&8 22.7±8.3 mg (range 11.3-43.3 mgld) with mean duration of LDAIprednisone of 189±43d (range 97-222d). Maximum prednisone dose was 60 mgld (mean 32.8±13.S mgld). No serio ... maternal complication. of LOAiprednisone were observed. One neonate had talipes cquinovarul that resolved without .urgical therapy. CONCLUSIONS: LOAiprednilOne therapy sccmed effcctiveaod well tolersted in thi. population. Thcac findings should be confirmed in a prospective, controlled investigation if such a trial can be organized and performed. 426 VERY EARLY THRO .. BOCYTOPENIA IN NEONATAL ALLOI .... UNE THRO .. BOCYTOPENIA. Johnson JM Blanchette VS', McFarland JG', Freedman J', Toi A', Wilson S', Morrow A. Univ of Toronto, Canada, Blood Bank of SE WISC, MiI,Wisc. OBJECTIVE: Neonatal a1loimmune Ibrombocytopenia (NAIT) is serious disorder cbaracterized by marked Ibrombocytopenia in the fetus and neonate. Intracrenlal hemonhage (ICH) allects l!O% of proven C88IIS (50% antell8laHy). Current therapeutic options Ibat may help elevate Ibe fetal platetet count before birth and prevent antenatal ICH in Ibe fetus are the maternal administration of high dose intrawnous gammaglobuHn with or without steroids, beginning at 20-22 weeks geetallon after determination of Ibe fetal platelet count and antigen status by cordocentesls. The purpose of this report Is to show Ibat fetal Ibrombocytopenla and ICH can occur before 22 weeks geslation and thet this may have Iberapuetic implications. STUDY DESIGN: This is a report of 2 cases of PLA negative women with anti-PLA 1 antibodies with 3 affected fetuses diagnosed before 22 _ks gestation. Fetal blood was obtained by cordocentesis in one case (case 1, 20 Weeks) and by intracardlac puncture prior 10 elective termination In 2 cases (cases 2 and 3, 16 and 13 weeks respectively). Detailed fetal serology, and ultraeound and postmortem examinations were obtained in eacb case. The results were compared to the available literature. RESULTS: Fetal thrombocytopenia was diagnosed al 20, 16 and 13 weeks gestation (platelet counts zero, 5,0001111, and 3,OOO/u1 respectively) &rid serology confirrmed affected fetusee (phenotypes PLA 111.2). In case 1, fetal dealb occurred at Ibe time of diagnostic cordocentesls. In case 2, ICH was diagnosed by ultrasound at 14 weeks gestation. Poetmortsm examination confirmed ICH and/or visceral hemonhage in all cases. CONCLUSION: These cases ara Ihe earliest Ibat antenatal diagnosis of fetal Ibrombocytopenla and ICH have ever been accornpHshed. We believe this identifies a sub-group of high-riSk petlents Ibet may benefit by Initiation of maternal Iberapy much earli4ll In gestation (eg, 12-14 weeks) Iban has been previously conslder8<l January 1993 Am J Obstct Gynecol 427 ANTIBIOTIC AMNIOINFUSION DOES NOT DECREASE MATERNAL MORBIDITY IN TERM PREGNANCY COMPLICATED BY AMNIONITIS. C. Macri, J, Paek, J. Greenspoon, R. Paul. Dept. Ob/Gyn, Univ. of Southern California, Los Angeles, CA. OBJECfIVE: The null hypothesis is that ampicillin amnioinfusion in patients with amnionitis will not decrease the incidence of febrile morbidity. STUDY DESIGN: Forty-six patients with amnionitis were prospectively randomized to receive ampicillin amnioinfusion (1 gram in 500 cc NaC1) plus IV ampicillin and gentamycin or standard care with IV ampicillin and gentamycin. Continuous variables were compared by one-way analysis of variance, and categoric variables were compared by X 2 analysis or Fisher's exact test. RESULTS: There was no difference in the frequency of cesarean delivery, postpartum febrile morbidity, or wound infections in the amnioinfusion vs control groups. CONCLUSIONS: Ampicillin amnioinfusion did not decrease the incidence of febrile morbidity in pregnancy complicated by chorioamnionitis. 428 PRERANDOMIZATION COMPLIANCE TESTING MAY PREDICT' PREGNANCY OUTCOME IN A RANDOMIZED CLINICAL TRIAl. A. Copper: J. Hauth, G. Cutter: M. DuBard: R. Goldenberg. Dept. of OB/GYN, University of Alabama at Birmingham, Birmingham, Al. OBJECTIVE: To assess pregnancy outcome in women who failed a 2-3 week placebo (PL) compliance test prior to randomization in a double- blind trial of low-dose aspirin (ASA). DESIGN: Nine hundred-seven healthy nulliparous women agreed to participate in a trial of daily ASA (60 mg) to prevent preeclampsia. All women underwent a 2-3 week PL compliance ("run-in") test. Three hundred-one women failed compliance testing and 606 were randomized to PL or ASA. Inclusion criteria and outcome data collection were identical for all participants. Randomized women continued their prenatal care in our Research Clinic, while those who failed compliance testing retumed to their usual public health clinics. Prenatal care was similar except that randomized patients had 2-3 extra prenatal visits and 3 routine ultrasound exams. RESULTS: Although the overall perinatal mortality rate (PNMR) was 8.8/1000, the PNMR was 20/1000 in the women who failed compliance testing compared to only 3.3f1000 in those randomized (p=0.01). In women who failed compliance testing, 3 of 6 perinatal deaths were associated with growth retardation and occurred at 35-36 weeks' gestation. Women who failed compliance testing also had a lower mean birthweight (3120 g vs. 3209 g, p=0.03) but similar gestational age at delivery (p=NS). They were more likely to be black (81% vs. 72%, p=0.002) and of lower education (11 y vs. 12 y, p=0.006). They had fewer indicated inductions of labor (13% vs. 25%, p<0.01), cesarean deliveries (16",(, vs. 23%, p-0.OO1), less oligohydramnios diagnosed (5% vs. 12%, p=0.001) and more growth retardation (17% vs. 13%, p=O.Og) than did women who were randomized. CONCLUSION: Participation in a clinical trial was associated with increased medical intervention, but a lower PNMR.

426 Very Early Thrombocytopenia in Neonatal Alloimmune Thrombocytopenia

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414 SPO Abstracts

425 TREATMENT OF PREGNANCY WSS (RPL) DUE TO "LUPUS ANTICOAGULANTS (LAC)" BY LOW-DOSE ASPIRIN (LDA) AND PREDNISONE. I.H. Harger, S.A. Laifer, Dept Ob/Oyn, Univ. of Pittsburgh Sch of Med, Pittsburgh, PA. OBJECTIVE: To ascer14in the complications and the efficacy of LOAiprednisone therapy in women with pregnancy 1088 and LAC. STUDY DESIGN: During 1986-92, 231 RPL patients were te&ted for LAC with an activated partial thromboplastin time (aP'IT) and a tissue thromboplastin index (TIl, normal value < 1.3). The diagnolis of LAC was estshlished if two TIl valu .. were 2: 1.3 or if a prolonged aYIT was measured in patient's plasma but did not correct to normal by I: I mixing with normal plasma. We excluded RPL patients baving only anticardiolipin antibodies. We treated 23 pregnancieo in 18 women with LOAiprednisone for RPL associated with LAC. Therapy with LDAlprcdnilODc was initiated as soon u • viable pregnancy or a LAC w .. diagnosed. Therapy was continued Until delivery in all but 1 case. Prednisone dose was minimized by measuring TIl every 2 weeks and adjusting the dose to maintain a ITI S 1.2 and to correct the aPlT. RESULTS: Of the 23 pregnancies, there were 4 (17%) first-trimester spontanco ... abortion. and 2 (9%) second-trimester fetal denth.. Of 17 surviving neonateo (74%), 6 delivered after 37 weeks and 11 before 37 weeks (mean 36.3 ±2.2 weeks; range 32.6-40.4 weeks). Prcterm premature rupture of membranes occurred in 3 pregnancies, prceclarnplia in 3, and 3 lmall-for­gestational age neonateo were delivered (2 stillborn). Mean birtbweight of 17 surviving neonaleo was 284Sg±6SOg (range 1420-3920g). Mean daily prednisone doac W&8 22.7±8.3 mg (range 11.3-43.3 mgld) with mean duration of LDAIprednisone of 189±43d (range 97-222d). Maximum prednisone dose was 60 mgld (mean 32.8±13.S mgld). No serio ... maternal complication. of LOAiprednisone were observed. One neonate had talipes cquinovarul that resolved without .urgical therapy. CONCLUSIONS: LOAiprednilOne therapy sccmed effcctiveaod well tolersted in thi. population. Thcac findings should be confirmed in a prospective, controlled investigation if such a trial can be organized and performed.

426 VERY EARLY THRO .. BOCYTOPENIA IN NEONATAL ALLOI .... UNE THRO .. BOCYTOPENIA. Johnson JM Blanchette VS', McFarland JG', Freedman J', Toi A', Wilson S', Morrow A. Univ of Toronto, Canada, Blood Bank of SE WISC, MiI,Wisc. OBJECTIVE: Neonatal a1loimmune Ibrombocytopenia (NAIT) is serious disorder cbaracterized by marked Ibrombocytopenia in the fetus and neonate. Intracrenlal hemonhage (ICH) allects l!O% of proven C88IIS (50% antell8laHy). Current therapeutic options Ibat may help elevate Ibe fetal platetet count before birth and prevent antenatal ICH in Ibe fetus are the maternal administration of high dose intrawnous gammaglobuHn with or without steroids, beginning at 20-22 weeks geetallon after determination of Ibe fetal platelet count and antigen status by cordocentesls. The purpose of this report Is to show Ibat fetal Ibrombocytopenla and ICH can occur before 22 weeks geslation and thet this may have Iberapuetic implications. STUDY DESIGN: This is a report of 2 cases of PLA negative women with anti-PLA 1 antibodies with 3 affected fetuses diagnosed before 22 _ks gestation. Fetal blood was obtained by cordocentesis in one case (case 1, 20 Weeks) and by intracardlac puncture prior 10 elective termination In 2 cases (cases 2 and 3, 16 and 13 weeks respectively). Detailed fetal serology, and ultraeound and postmortem examinations were obtained in eacb case. The results were compared to the available literature. RESULTS: Fetal thrombocytopenia was diagnosed al 20, 16 and 13 weeks gestation (platelet counts zero, 5,0001111, and 3,OOO/u1 respectively) &rid serology confirrmed affected fetusee (phenotypes PLA 111.2). In case 1, fetal dealb occurred at Ibe time of diagnostic cordocentesls. In case 2, ICH was diagnosed by ultrasound at 14 weeks gestation. Poetmortsm examination confirmed ICH and/or visceral hemonhage in all cases. CONCLUSION: These cases ara Ihe earliest Ibat antenatal diagnosis of fetal Ibrombocytopenla and ICH have ever been accornpHshed. We believe this identifies a sub-group of high-riSk petlents Ibet may benefit by Initiation of maternal Iberapy much earli4ll In gestation (eg, 12-14 weeks) Iban has been previously conslder8<l

January 1993 Am J Obstct Gynecol

427 ANTIBIOTIC AMNIOINFUSION DOES NOT DECREASE MATERNAL MORBIDITY IN TERM PREGNANCY COMPLICATED BY AMNIONITIS. C. Macri, J, Paek, J. Greenspoon, R. Paul. Dept. Ob/Gyn, Univ. of Southern California, Los Angeles, CA. OBJECfIVE: The null hypothesis is that ampicillin amnioinfusion in patients with amnionitis will not decrease the incidence of febrile morbidity. STUDY DESIGN: Forty-six patients with amnionitis were prospectively randomized to receive ampicillin amnioinfusion (1 gram in 500 cc NaC1) plus IV ampicillin and gentamycin or standard care with IV ampicillin and gentamycin. Continuous variables were compared by one-way analysis of variance, and categoric variables were compared by X2 analysis or Fisher's exact test. RESULTS: There was no difference in the frequency of cesarean delivery, postpartum febrile morbidity, or wound infections in the amnioinfusion vs control groups. CONCLUSIONS: Ampicillin amnioinfusion did not decrease the incidence of febrile morbidity in pregnancy complicated by chorioamnionitis.

428 PRERANDOMIZATION COMPLIANCE TESTING MAY PREDICT' PREGNANCY OUTCOME IN A RANDOMIZED CLINICAL TRIAl. A. Copper: J. Hauth, G. Cutter: M. DuBard: R. Goldenberg. Dept. of OB/GYN, University of Alabama at Birmingham, Birmingham, Al. OBJECTIVE: To assess pregnancy outcome in women who failed a 2-3 week placebo (PL) compliance test prior to randomization in a double­blind trial of low-dose aspirin (ASA). DESIGN: Nine hundred-seven healthy nulliparous women agreed to participate in a trial of daily ASA (60 mg) to prevent preeclampsia. All women underwent a 2-3 week PL compliance ("run-in") test. Three hundred-one women failed compliance testing and 606 were randomized to PL or ASA. Inclusion criteria and outcome data collection were identical for all participants. Randomized women continued their prenatal care in our Research Clinic, while those who failed compliance testing retumed to their usual public health clinics. Prenatal care was similar except that randomized patients had 2-3 extra prenatal visits and 3 routine ultrasound exams. RESULTS: Although the overall perinatal mortality rate (PNMR) was 8.8/1000, the PNMR was 20/1000 in the women who failed compliance testing compared to only 3.3f1000 in those randomized (p=0.01). In women who failed compliance testing, 3 of 6 perinatal deaths were associated with growth retardation and occurred at 35-36 weeks' gestation. Women who failed compliance testing also had a lower mean birthweight (3120 g vs. 3209 g, p=0.03) but similar gestational age at delivery (p=NS). They were more likely to be black (81% vs. 72%, p=0.002) and of lower education (11 y vs. 12 y, p=0.006). They had fewer indicated inductions of labor (13% vs. 25%, p<0.01), cesarean deliveries (16",(, vs. 23%, p-0.OO1), less oligohydramnios diagnosed (5% vs. 12%, p=0.001) and more growth retardation (17% vs. 13%, p=O.Og) than did women who were randomized. CONCLUSION: Participation in a clinical trial was associated with increased medical intervention, but a lower PNMR.